BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAGEN TEST IMPLANT

    MDR report key: 162628 · Received April 14, 1998

    Report

    Report Number
    2939859-1998-00102
    Event Type
    Injury
    Date Received
    April 14, 1998
    Date of Event
    September 11, 1997
    Report Date
    March 19, 1998
    Manufacturer
    COLLAGEN CORP
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED A PT WHO RECEIVED HER FIRST SKIN TEST IN THE RIGHT FOREARM 9/10/1997. ON 9/11/1997, THE PT PHONED THE PHYSICIAN AND REPORTED THAT SHE HAD REDNESS, ITCHING AND BUMPINESS AT THE TEST SITE. THE PHYSICIAN BELIEVED THE PT HAD DEVELOPED A HYPERSENSITIVITY, AND INSTRUCTED THE PT TO TAKE ORAL BENADRYL FOR THE SYMPTOMS. NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS PLANNED OR PRESCRIBED, AND THERE HAD BEEN NO ADDITIONAL PT FOLLOW UP SINCE 9/11/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAGEN TEST IMPLANT Implant COLLAGEN TEST IMPLANT LMH COLLAGEN CORP NA 96H155B

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention